The Omni Foot Plaing System is internal fixation of arthrodeses, osteotomies, fractures and nonunions of the small bones of the foot & ankle including the fore-, mid-, and hind foot and ankle applications.

Device Description

The Omni Foot Plating System is a bone fixation system consisting of unalloyed Titanium plates and Titanium Alloy (Ti-6AL-4V) locking and non-locking plate screws, which meet ASTM F67 and ASTM F136, and a set of instruments used for implant site preparation and delivery. The plates are available in various configurations, essentially differing by the lengths and number of holes. The plate screws are provided in diameters of 2.8mm and 3.5mm in lengths from 8mm to 50mm. The System offers 3.5mm cannulated screws in various lengths to be used as adjunctive fixation. The 3.5mm cannulated screw can also be used with a specialized locking screw ("Post") which contains a locking feature at the distal end for compression/stabilization.

AI/ML Overview

This document is a 510(k) premarket notification for the Omni Foot Plating System, a medical device. It does not describe an AI/ML device or present data from a study to prove a device meets acceptance criteria related to AI/ML performance. Instead, it demonstrates substantial equivalence to predicate devices through engineering analysis and materials comparison.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device performance for an AI/ML system, as this document pertains to a traditional metallic bone fixation system.

Specifically:

Table of acceptance criteria and reported device performance: Not applicable. This document is about a mechanical device, not an AI/ML system with performance metrics like sensitivity, specificity, etc.
Sample size for test set and data provenance: Not applicable. No test set for AI/ML performance. The engineering analysis compares mechanical properties.
Number of experts and qualifications for ground truth: Not applicable. Ground truth as typically defined for AI/ML (e.g., disease diagnosis) is not relevant here.
Adjudication method for test set: Not applicable.
MRMC comparative effectiveness study: Not applicable. This is not an AI-assisted diagnostic device.
Standalone (algorithm only) performance: Not applicable. This is a physical device, not an algorithm.
Type of ground truth used: Not applicable for AI/ML. The "ground truth" for this device's performance would be engineering standards and material properties, confirmed by engineering analysis.
Sample size for training set: Not applicable. There is no AI/ML model to train.
How ground truth for training set was established: Not applicable.

Summary

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May 22, 2018

Extremity Medical, LLC Brian Smekal VP, Regulatory Affairs and Quality Assurance 300 Interpace Parkway, Suite 410 Parsippany, New Jersey 07054

Re: K180808

Trade/Device Name: Omni Foot Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: March 27, 2018 Received: March 28, 2018

Dear Brian Smekal:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Katherine D. Kavlock -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K180808

Device Name Omni Foot Plating System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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K180808 Page 1 of 2

510(k) Summary

Omni Foot Plating System

Submitter	Extremity Medical, LLC.300 Interpace Parkway, Suite 410Parsippany, NJ 07054
Contact Person	Brian Smekal, MS, RACVP, Regulatory Affairs and Quality AssurancePhone: (973) 588-8988Email: bsmekal@extremitymedical.com
Date Prepared	May 10, 2018
Trade Name	Omni Foot Plating System
Common Name	Bone plates and screws
ClassificationName andNumber	21 CFR 888.3030 - Single/multiple component metallic bone fixation appliances andaccessories; 21 CFR 888.3040 - Smooth or threaded metallic bone fixation fastener
Product Code	HRS, HWC
PredicateDevices	K172260 - Omni Foot Plating SystemK170780 - Arix Foot System (2.3/2.8)K161864 – Arix Foot SystemK143188 - 3.0mm Biomet Cannulated Screw System
DeviceDescription	The Omni Foot Plating System is a bone fixation system consisting of unalloyed Titaniumplates and Titanium Alloy (Ti-6AL-4V) locking and non-locking plate screws, which meetASTM F67 and ASTM F136, and a set of instruments used for implant site preparation anddelivery. The plates are available in various configurations, essentially differing by thelengths and number of holes. The plate screws are provided in diameters of 2.8mm and3.5mm in lengths from 8mm to 50mm. The System offers 3.5mm cannulated screws invarious lengths to be used as adjunctive fixation. The 3.5mm cannulated screw can also beused with a specialized locking screw ("Post") which contains a locking feature at the distalend for compression/stabilization.
Indications foruse	The Omni Foot Plating System is intended for use in internal fixation of arthrodeses,osteotomies, fractures and nonunions of the small bones of the foot & ankle including thefore-, mid-, and hind foot and ankle applications.
Statement ofTechnologicalComparison	Omni Foot System, Bone Plates: Based on a technical feature comparison, the subjectdevice was found to be similar to all predicate devices with regard to design and materials.The subject plates also have a polyaxial locking feature, identical to the design used in thepredicate device (K161864 and K170780).Omni Foot System, Bone Screws: They are identical in design of the screws previouslycleared under K172260 – Omni Foot Plating System.
Non-clinicalTesting	The new geometries of the Omni Foot plates were compared to the Arix Foot System plates(K161864 and K170780) by engineering analysis. The results of this analysis indicate thatthe Omni Foot Plating System is equivalent to predicate device.
Clinical Testing	No clinical testing was performed.
Conclusion	The Omni Foot Plating System is substantially equivalent to its predicate devices. Thisconclusion is based upon indications for use, principles of operation, design, andengineering analysis.

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Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.